HPR116 the Impact of Policy Measures to Increase the Uptake of Biosimilar Medicines in Belgium: A Nationwide Interrupted Time Series Analysis

Belgium has experienced a malfunctioning off-patent biologicals market since the entry of the first biosimilar more than a decade ago. Therefore, the Belgian government has taken several measures to increase the uptake of biosimilars in past years. However, no formal evaluation of the impact of these measures has been made yet. This study aimed to investigate the impact of the implemented measures. An interrupted time series analysis was performed using an Autoregressive Integrated Moving Average (ARIMA) model. All data were expressed as Defined Daily Doses (DDD) per month/quarter and obtained from the Belgian National Institute for Health and Disability Insurance. Three molecules were included in the analysis: etanercept (ambulatory), filgrastim (hospital), and epoetin (hospital). A significance level of 5% was used for all statistical analyses. In the ambulatory care, the effect of a financial prescriber incentive of 2019 was investigated. After the intervention, the positive trend in monthly etanercept biosimilar dispensings decreased slightly with 44.504 DDD(p<0.001). For hospital biosimilars, two interventions were modelled. The first intervention of 2016 includes prescription targets for biosimilars and monitoring of hospitals on adequate tendering. The second intervention involves an information campaign on biosimilars for Belgian healthcare providers and patients. A small decrease in the positive trend in quarterly epoetin biosimilar uptake of 449.820 DDD(p=0.05) was observed after the first intervention. A larger increase in the upward trend of 2733.692 DDD(p<0.001) was detected after the second intervention. For filgrastim, the positive trend decreased with 151.639 DDD(p<0.001) after te first intervention. An immediate and sustained increase of 700.932 DDD(p=0.016) in quarterly filgrastim biosimilar volume was observed after the second intervention. All other parameter estimates were not statistically significant. The study results suggest that the impact of the past Belgian policy interventions to increase the uptake of biosimilars has been limited, especially in the ambulatory care.